Supplier Controls to Meet Tougher U.S. FDA Requirements - Webinar By ComplianceOnline (Medical Device)
Venue: Online Event
|Event Date/Time: May 22, 2012||End Date/Time: May 22, 2012|
Recent FDA statements and actions indicate the past ways of managing a company's supply chain / outsourcing will no longer be acceptable. Increasingly reports from the field indicate that the Agency is using high-profile cases to drive compliance to smaller companies and suppliers. CGMP compliance cannot be passed on to suppliers; however suppliers must meet specific CGMP requirements. Proof for "better science" is also a new expectation. "Business as usual" is never acceptable. Don't be caught of guard by these major shifts in emphasis.
This presentation will help you refine supplier management and audits to match the FDA's tougher position. We will evaluate the chief areas of change to see how to better prepare a supplier chain management and audit program. This webinar will provide valuable assistance to all regulated companies in evaluating their existing supply chain control / compliance and vendor audits in light of the changes in the FDA's CGMP supplier management "paradigm". Once potential problem areas are identified, a company can evaluate / perform a gap analysis, and then put in place the necessary fixes to ensure continuing compliance.
- The Globalization of the Supply Chain and What That Means
- Avoid complacency from past "good" FDA / ISO audits
- Supplier Ranking Models
- Essential Supplier Controls
- Where to direct scarce resources
- The Tiered Risk-Based Audit Approach
- Maintain "the edge"; proactively address "entropy"